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Recall Observatory FDA recall evidence

Device product

25 gauge VersaVit 2.0 Procedure Pack with Mid-Field Illuminator, Product/Part Number 70025S, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system.

Z-0120-2017

August 11, 2016

Class II

Product summary

Firm
Synergetics Inc
Event
Event 74918
Status
Terminated
Classification
Class II
Quantity
72 units
Official record key
device-enforcement:Z-0120-2017

Official wording

Reason: Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.

Code information: Lot number M548370 (1 each or box of 6 each), exp 11/2018 Lot number M578150 (1 each or box of 6 each), exp 02/2019

Distribution pattern: Devices were distributed to KY, VA, TN, OH, IN, CA, NJ, NY, TX, SC, AL, MS, MI, and UT. Foreign distribution to the UK, France, Mexico, and India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Vitrectomy cutters have been found not to be operating within the correct pressure pulse per specification.